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Recall Observatory FDA recall evidence

Device product

JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;

Z-1424-2018

February 23, 2017

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 76620
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1424-2018

Official wording

Reason: The integrity of the sterile packaging is potentially compromised.

Code information: Product Code: a.) TJC3513 / LOT 0000848831, 0000851431, 0000854856; Product Code: b.) TJC4008 / LOT 0000841227, 0000846706, 0000848560, 0000849684, 0000853455; c.) TJC4011 / LOT 0000840667, 0000841228, 0000845874, 0000849717, 0000850937, 0000852121; d.) TJC6008 / LOT 0000841216, 0000848569, 0000851432, 0000852122, 0000853458; e.) TJC6011 / LOT 0000841124, 0000848571, 0000853975

Distribution pattern: Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile packaging is potentially compromised